(92 days)
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof. reconstruction in cases of defects after fracture. acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis. hemi-arthroplasty. or total hip replacement.
The Zimmer Trabecular Metal Acetabular Revision System Cage is a device intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiencies, such as pelvic defects and discontinuities. The cage is a metallic, dome-shaped, flanged acetabular component with multiple screw holes for adjunct intraoperative peripheral stabilization of revision shell constructs. The cage is available in five sizes configured in both right and left versions along with either short or long flanges to meet various anatomical needs. It offers intraoperative flexibility of implant orientation/positioning to accommodate patient anatomies. The cage is fabricated from Commercially Pure (CP) Titanium
Here's an analysis of the provided text regarding the Zimmer Trabecular Metal™ Acetabular Revision System Cage, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device is a medical implant (Acetabular Cage), and the review focuses on substantial equivalence to a predicate device rather than performance against predetermined acceptance criteria typically seen in clinical trials for diagnostic devices or new technologies.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Substantial Equivalence to Predicate Device | * Intended Use: Both the proposed device and the predicate (Burch/Schneider™ Reinforcement Cage, K960678) are intended for revision hip surgeries to bridge areas of acetabular bone loss in patients with acetabular bone deficiency. * Non-Clinical Performance: Engineering evaluations were performed to verify that the performance of the device would be adequate for anticipated in vivo use. |
| Safety and Effectiveness | * The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the FDA believes the device is as safe and effective as its predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a test set in the manner of a diagnostic device or a new therapeutic intervention. Instead, it refers to design verification through non-clinical engineering evaluations.
- Sample Size for Test Set: Not applicable in the context of a clinical test set. The document refers to "engineering evaluations," which would involve testing of prototypes or materials according to established standards. The sample sizes for these engineering tests are not specified.
- Data Provenance: Not applicable for a clinical test set. The "engineering evaluations" would have been conducted by the manufacturer, Zimmer, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or provided because the review is based on substantial equivalence to a predicate device and non-clinical engineering evaluations, not a clinical study requiring ground truth established by expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable or provided as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done based on the provided text. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This question is not applicable as the device is a physical medical implant (Acetabular Cage), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is irrelevant.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in clinical or diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. The device's safety and effectiveness were established through:
- Substantial equivalence to a legally marketed predicate device.
- Non-clinical engineering evaluations to verify performance against anticipated in vivo use. The "ground truth" for these engineering evaluations would be established engineering standards, material properties, and biomechanical principles.
8. The Sample Size for the Training Set
This information is not applicable or provided. The document details a 510(k) premarket notification for a physical medical device, not an AI or machine learning algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided for the same reasons as #8.
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Summary of Safety and Effectiveness
AUG 0 2 2006
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Patricia JenksSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8354Fax: (574) 372-4605 |
| Date: | July 26, 2006 |
| Trade Name: | Zimmer Trabecular Metal™ Acetabular RevisionSystem Cage |
| Common Name: | Acetabular Cage |
| Classification Nameand Reference: | Prosthesis, Hip, Semi-constrained, Metal/Polymer,Porous, Uncemented21 CFR § 888.3358 |
| Predicate Device: | Burch/Schneider™ Reinforcement Cage, K960678,cleared May 3, 1996, manufactured by ZimmerGmbH (formerly Centerpulse Orthopedics Ltd.) |
| Device Description: | The Zimmer Trabecular Metal Acetabular RevisionSystem Cage is a device intended to bridge theareas of acetabular bone loss in patients withacetabular bone deficiencies, such as pelvic defectsand discontinuities. The cage is a metallic, dome-shaped, flanged acetabular component with multiplescrew holes for adjunct intraoperative peripheralstabilization of revision shell constructs.The cage is available in five sizes configured inboth right and left versions along with either shortor long flanges to meet various anatomical needs. Itoffers intraoperative flexibility of implantorientation/positioning to accommodate patientanatomies. The cage is fabricated fromCommercially Pure (CP) Titanium |
| Intended Use: | This device is intended for cemented use only aspart of a layered construct and is indicated forpatients with conditions of, but not limited to,acetabular dysplasia, osteoporosis, protrusioacetabuli, cystic acetabular roof, reconstruction incases of defects after fracture, acetabular loosening,tumors or revision surgery, advanced jointdestruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failedprevious surgery, e.g., osteosynthesis, jointreconstruction, arthrodesis, hemi-arthroplasty, ortotal hip replacement. |
| Comparison to Predicate Device: | Both the predicate and proposed devices areintended for revision hip surgeries to bridge theareas of acetabular bone loss in patients withacetabular bone deficiency. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Engineering evaluations were performed to verifythat the performance of the device would beadequate for anticipated in vivo use.Clinical Performance and Conclusions:Clinical data and conclusions were not needed forthis device. |
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2006
Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K061226
Trade/Device Name: Trabecular Metal Acetabular Revision System Cage Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH Dated: July 26, 2006 Received: July 27, 2006
Dear Ms. Jenks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning vour device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Patricia Jenks
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Halut Lener Lwo
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Trabecular Metal™ Acetabular Revision System Cage
Indications for Use:
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof. reconstruction in cases of defects after fracture. acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis. hemi-arthroplasty. or total hip replacement.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line -- Continue on another page if needed)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Hubert Lemer
(Division Sig) :-Division of Georgi, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number L061226
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.